Bioethics and Informed Consent in Prenatal Diagnostics
DOI:
https://doi.org/10.15633/pch.13107Keywords:
Informed consent, bioethics, chromosomal anomalies, prenatal diagnosticsAbstract
Innovative methods of prenatal diagnosis allow us to see the development of the fetus and to detect early disorders of fetal development, which may lead to an early diagnosis and possible treatment, or to a woman’s decision to terminate the pregnancy. Therefore, it is very important to accurately inform a woman about the risks and consequences of this life-related issue, even before deciding to perform prenatal tests; and after the results, when a misinterpreted diagnosis may lead a woman to terminate her pregnancy. The obligation of doctors to inform patients is inseparable from the requirement to receive informed consent. The two parts are mandatory for any medical procedure and intervention. The main requirements for the informed consent include rationality, sufficient and clear information, free will, and the form of consent conforming to the legal acts. However, informed consent is not an absolute requirement, as the patient has a right to remain uninformed. Additionally, under certain circumstances, it might be impossible to inform patients, or to receive consent from patients or their duly authorized representatives. Prenatal testing is an integral part of ante-natal care that aims to verify the proper development of the fetus, or to identify potential hereditary or chromosomal diseases at the earliest possible stage. Prenatal testing can be classified as non-invasive or invasive measures, according to the types of procedures In addition to this, according to the aim of the procedure, into diagnostic prenatal testing with the aim of prenatal therapy, and purely diagnostic prenatal testing. Purely diagnostic prenatal testing is closely connected with the problem of selective abortion.
Part of this article covers the main problems of informed consent in prenatal diagnostics, by outlining two stages of the process: conveyance before prenatal testing, and interpretation of the results alongside presentation of the possible choices. The legal implications we consider are based on information from other European countries: we name the main questions analyzed by courts, including cases of “wrongful birth” and “wrongful life”; inappropriate information regarding possibilities of abortion; the right of a woman to use all available diagnostic methods; and the allocation of damages to the claimants.
References
Alberry M. S., Aziz E, Ahmed S. R., Abdel-Fattah S., Non invasive prenatal testing (NIPT) for common aneuploidies and beyond, “Eur J Obstet Gynecol Reprod Biol.“ (2021) Mar; 258, pp. 424–429.
Baker J., Shuman C., Chitayat D., Wasim S., Okun N., Keunen J., Hofstedter R., Silver R., Informed Decision-Making in the Context of Prenatal Chromosomal Microarray, “J Genet Couns.“ (2018) Sep; 27 (5), pp. 1130–1147.
Bar V. C., Non-Contractual Liability Arising out of Damage Caused to Another (2009), pp. 352.
Berlin L., Wrongful life. Malpractice issues in radiology, “American journal of roentgenology“ (2003) 181, pp. 1181–1188.
Brown M.T., The Moral Status of the Human Embryo, “J Med Philos.“ (2018) Mar 13; 43 (2), pp. 132–158.
Brüggemeier G., Ciacchi A. C., O’Callaghan P., Personality Rights in European Tort Law, (2010), pp. 525–526.
Case 27617/04, R.R. v. Poland [2011] ECR.
Chervenak F. A., McCullough L.B., Professionally Responsible Counseling About Fetal Analysis, “Obstet Gynecol Clin North Am.“ (2021) Dec; 48 (4), pp. 777–785.
Dahl K., Kesmodel U., Hvidman L., Olesen F., Informed consent: attitudes, knowledge and information concerning prenatal examinations, “Acta Obstetricia et Gynecologica“ (2006) Nr. 85, pp. 1414–1419.
Dukhovny S., Norton M.E., What are the goals of prenatal genetic testing?, “Semin Perinatol.“ (2018) Aug; 42 (5), pp. 270–274.
Dundar M., Uzak A. S., Erdogan M., Akbarova Y., Prediction, prevention and personalisation of medication for the prenatal period: genetic prenatal tests for both rare and common diseases, “EPMA Journal“ (2011) Nr. 2, pp. 181–195.
Fry J., Antiel R. M., Michelson K., Rowell E., Ethics in prenatal consultation for surgically correctable anomalies and fetal intervention, “Semin Pediatr Surg.“ (2021) Oct; 30 (5), pp. 151102.
Geissler K. H., Pearlman J., Attanasio L.B., Physician Referrals During Prenatal Care, “Matern Child Health J.“ (2021) Dec; 25 (12), pp. 1820–1828.
Giesen I., Of wrongful birth, wrongful life, comparative law ant the politics of tort law system, “Tydskrif vir Heedendaagse Romeins-Hollandse Reg (THRHR)“ (2009) Nr. 72, pp. 257.
Huster S., Non-invasive prenatal diagnostics (NIPD) in the system of medical care. Ethical and legal issues, “J Perinat Med.“ (2021) May 31; 49 (8), pp. 972–978.
Jong D. A., Dondorp J. W., Die-Smulders C. E. D., Frints G. M. S., Wert D. M. W. R. G., Non-invasive prenatal testing: ethical issues explored., “European Journal of Human Genetics“ (2010) Nr. 18, pp. 272–277.
Kater-Kuipers A., de Beaufort I. D., Galjaard R. H., Bunnik E. M., Rethinking counselling in prenatal screening: An ethical analysis of informed consent in the context of noninvasive prenatal testing (NIPT), “Bioethics“ (2020) Sep; 34 (7), pp. 671–678.
Kiani A. K., Paolacci S., Scanzano P., Michelini S., Capodicasa N., D’Agruma L., Notarangelo A., Tonini G., Piccinelli D., Farshid K. R. Petralia P., Fulcheri E., Buffelli F., Chiurazzi P., Terranova C., Plotti F., Angioli R., Castori M., Pös O., Szemes T., Bertelli M., Prenatal genetic diagnosis: Fetal therapy as a possible solution to a positive test, “Acta Biomed.“ (2020) Nov 9; 91 (13-S): e2020021.
Milinković N., Ignjatović S., Šumarac Z., Majkić-Singh N., Uncertainty of Measurement in Laboratory Medicine, “J Med Biochem.“ (2018) Jul 1; 37 (3), pp. 279–288.
National Conference of a Catholic Bishops Science and Human Values Committee, Critical Decisions: Genetic Testing and its Implications, “Origins“ 25: no 45 (May 2, 1996), pp. 770.
Pope John Paul II., The Gospel of Life, (Mar. 25, 1995), no. 63, Origins 24: no. 42, Apr. 6, 1995, pp. 711.
Potter K. B., Reilly O. R. et. al., Exploring informed choice in the context of prenatal testing: findings from a qualitative study, “Health Expectations“ (2008) Nr. 11, pp. 355–365.
Rowe H. J., Fisher W. R. J., Quinlivan A. J., Are pregnant Australian women well informed about prenatal genetic screening? A systematic investigation using the Multidimensional Measure of Informed Choice, “Australian and New Zealand Journal of Obstetrics and Gynaecology“ (2006) Nr. 46, pp. 433–439.
Schmitz D., Henn W., The fetus in the age of the genome, “Hum Genet.“ (2021) Aug 23. Epub ahead of print.
Sivanadarajah N., El-Daly I., Mamarelis G., Sohail M. Z., Bates P., Informed consent and the readability of the written consent form, “Ann R Coll Surg Engl.“ (2017) Nov; 99 (8), pp. 645–649.
Suter S. M., The routinization of prenatal testing, “American journal of law and medicine“ (2002) Nr. 28, pp. 233–270.
Tan C. M. J., Lewandowski A. J., The Transitional Heart: From Early Embryonic and Fetal Development to Neonatal Life, “Fetal Diagn Ther.“ (2020) 47 (5), pp. 373–386.
Tobola-Wrobel K., Wysocka E., Pietryga M., The clinical usefulness of biochemical (free β-hCg, PaPP-a) and ultrasound (nuchal translucency) parameters in prenatal screening of trisomy 21 in the first trimester of pregnancy, “Ginekol Pol.“ (2019) 90 (3), pp. 161–166.
Vikas H., Kini A., Sharma N., Gowda N. R., Gupta A., How informed is the informed consent?, “J Family Med Prim Care“ (2021) Jun; 10 (6), pp. 2299–2303.
Zerres K., Rudnik-Schöneborn S., Holzgreve W., Do non-invasive prenatal tests promote discrimination against people with Down syndrome? What should be done? “J Perinat Med.“ (2021) May 31; 49 (8), pp. 965–971.
Downloads
Published
Issue
Section
License
![Creative Commons License](http://i.creativecommons.org/l/by/4.0/88x31.png)
This work is licensed under a Creative Commons Attribution 4.0 International License.
The author declares that he or she has full copyright to the work, and such copyright it is not limited to the extent applicable to this declaration, that the article is an original work and that it does not infringe any third-party rights.
The author agrees to a free-of-charge, non-exclusive and non-restricted use of the work by Pontifical University of John Paul II in Krakow i.e.:
- to record and duplicate: make copies of the work by means of printing, reprography, magnetic or digital storage;
- to circulate the original or the copies of the work (disseminate, lend or lease the original or copies thereof, publicly display, screen or make the work publicly available so that everyone is able to access it at the time and in place they wish to do so);
- to include the work in a compilation;
- the Pontifical University of John Paul II in Krakow may grant sublicenses Creative Commons Acknowledgement of authorship-Non-commercial use-Without derivative work 3.0 Poland
The Pontifical University of John Paul II in Krakow makes the work available on the Journals Platform belonging to the University, according to the licence Creative Commons Acknowledgement of authorship-Non-commercial use-Without derivative work 3.0 Poland. Accordingly, the author authorises all interested parties to use the work on the following conditions:
- the author and the title of the work will be listed,
- the place of publication (name of the periodical and an Internet link to the originally published work),
- the work will be distributed in a non-commercial way,
- no derivative works will be created.
The UPJPII Press does not waive any of its copyrights to any target group.